RF Ablation of Atrial Fibrillation

NCT00265629 | Completed Phase 1

• 1 other identifier: BEP-4405
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation. This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety of the HDMA when used to map & ablate patients with AF, by assessing MCs at 7-days & 30 days post-procedure & assessing the occurrence of pulmonary vein stenosis at 3 & 12 months post-procedure.

  12 months

• Evaluate the preliminary effectiveness of the HDMA when used to map and ablate patients with paroxysmal AF, by assessing APS & the freedom from recurrence of symptomatic AF at 3, 6 & 12 months post- procedure.

  12 months

Study Arms (1)

1

EXPERIMENTAL

RF ablation

Device: RF catheter ablation

Interventions

RF catheter ablation DEVICE

RF ablation using mesh device

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are between 18 \& 85 years of age.
• Patients with a minimum of 2 episodes of symptomatic PAF within the last 6 months prior to baseline evaluation. At least one of these episodes must have been documented. Documentation may include electrocardiogram (ECG), trans telephonic monitoring (TTM), Holter monitoring (HM), or telemetry strip. Additional PAF episodes (i.e., verbal accounts from the patient) will be documented in the patient's study record.
• Patients who have failed at least 1 class I or class III anti-arrhythmic medication regimen.
• Patients with the ability to understand the requirements of the study, who have provided written informed consent and agreed to the study restrictions and to return for the required follow-up assessments.

You may not qualify if:

• Any previous ablation of the left atrium (surgical or catheter based).
• Permanent or persistent atrial fibrillation.
• Recent myocardial infarction within 2 months
• Currently unstable angina.
• Any cardiac surgery during the previous 3 months.
• Currently documented intracardiac thrombus by transesophageal echocardiography (TEE).
• A left atrium \> 50mm in major dimension.
• A common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis.
• Permanent leads in or through the right atrium.
• Clinically significant valvular heart disease or a replacement heart valve.
• Congestive heart failure (NYHA classification III or IV).
• An ejection fraction \<35%.
• A contraindication to warfarin.
• A contraindication to transseptal procedure.
• Any cerebral ischemic event, including any transient ischemic attack (TIA), in the preceding 6 months.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

David Haines, MD

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: August 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)